AB0535 EFFICACY AND SAFETY OF BELIMUMAB IN PATIENTS WITH CHILDHOOD-ONSET SYSTEMIC LUPUS ERYTHEMATOSUS:A SYSTEMATIC REVIEW AND META-ANALYSIS
Authors: L. Yang, Q. Y. Su, R. X. E. Yang, J. J. Cao, P. Su, H. Niu, S. L. Liu, J. Q. LI, Q. Yu, P. F. He, X. LI, S. X. Zhang
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Childhood-onset systemic lupus erythematosus (cSLE) is associated with higher disease severity than adult-onset lupus. Abnormal activation of B cells is a crucial link in their pathogenesis. Belimumab is a specific inhibitor of the soluble B lymphocyte stimulator and inhibits its binding to receptors and thus its activity <sup>[1,2]</sup>. However, the current clinical research evidence of this drug in children is insufficient, the relevant clinical data are mostly from prospective studies in adults,and there are no exact guidelines for clinical application in children. <h3>Objectives</h3> This study aimed to investigate the efficacy and safety of belimumab for treating children with cSLE. <h3>Methods</h3> We systematically searched PubMed, EMBASE, Wan Fang Data,Web of Science, the Cochrane Library, and Medline for randomized controlled trials, original case reports, and case series that described belimumab's efficacy in treating cSLE. A random-effects meta-analysis was performed to calculate its efficacy. Inconsistency was evaluated using the I2 and Egger tests to evaluate potential publication bias (STATA v.12.0). <h3>Results</h3> Five studies with 325 patients were included in the meta-analysis (Table 1). The age range of the included participants was less than 18 years; most were women. All patients received belimumab at a dosage of 10 mg/kg every 2 weeks for the first three doses, then every 4 weeks thereafter. SLEDAI-2K was the main score,which was significantly reduced compared with the baseline[SMD= -1.106, 95%CI (-1.311,-0.901), P&lt;0.001]. The number of oral corticosteroids was significantly decreased after the belimumab therapy[SMD = -1.21,95%CI (-1.72, -0.70), P&lt;0.001]. Both Anti-double stranded DNA (Anti-dsDNA) and anti-nuclear antibodies (ANA) positive patients also decreased obviously[RR= 0.56, 95%CI (0.37,0.85), P=0.007; RR= 0.90, 95%CI (0.83,0.98), P=0.012]. Infection and thrush were the main adverse effects with rates of 26% and 4%,respectively, but all were classified as mild-moderate treatment-emergent adverse events. Serious adverse reactions are rarely reported. <h3>Conclusion</h3> Belimumab treatment in cSLE minimizes the use of hormones, and the incidence of adverse events such as infections was low, suggesting belimumab can effectively reduce disease activity safely and reliably. Long-term efficacy and safety still need a multicenter, large sample, long-term, in-depth research. <h3>References</h3> [1]Kamphuis S, Silverman ED. Prevalence and burden of pediatric-onset systemic lupus erythematosus. Nat Rev Rheumatol. 2010 Sep;6(9):538-46. doi: 10.1038/nrrheum.2010.121. Epub 2010 Aug 3. PMID: 20683438. [2]Hahn BH. Belimumab for systemic lupus erythematosus. N Engl J Med. 2013 Apr 18;368(16):1528-35. doi: 10.1056/NEJMct1207259. PMID: 23594005. <h3>Acknowledgements</h3> This work was supported by the National Natural Science Foundation of China (No. 82001740). <h3>Disclosure of Interests</h3> None Declared.